FDA 510(k)

Electronic Caries Detector

K-Number: K170822 · 2017-09-11

Decision Date2017-09-11

Product CodeNBL

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Electronic Caries Detector is the device name listed in this FDA 510(k) record. The listed applicant is Ortek Therapeutics, Inc.. It received FDA 510(k) clearance on 2017-09-11 under 510(k) number K170822. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electronic Caries Detector?

Electronic Caries Detector is a medical device that received FDA 510(k) clearance on 2017-09-11. The listed applicant is Ortek Therapeutics, Inc.. The 510(k) number is K170822.

When did Electronic Caries Detector receive FDA 510(k) clearance?

Electronic Caries Detector received FDA 510(k) clearance on 2017-09-11, under 510(k) number K170822.

Who is the listed applicant for Electronic Caries Detector?

The FDA 510(k) record lists Ortek Therapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Electronic Caries Detector?

The FDA product code for Electronic Caries Detector is NBL.

Related Devices (Code: NBL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.